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2019 Volume 10 Issue 1

Method Development and Validation of High Performance Liquid Chromatography Method for Methylparaben and Butylparaben in Ointment Form


Gunasekar Manoharan, Ramadan Abdel Wahed Mohamed
Abstract

The main aim of this study was to investigate the performance of development method for methylparaben and butylparaben determination in skin ointment product by High Performance Liquid Chromatography (HPLC). The method validation parameters were evaluated as per International Conference on Harmonisation (ICH) Guidelines. The method shows the specificity has retention time of methylparaben and butylparaben at 2.10 minutes and 6.64 minutes, respectively. The mobile phase had acetonitrile, methanol and phosphate buffer with the ratio of 10:40:50 v/v. The flow rate was set as 1 ml/minute and the maximum absorption was observed at 270 nm using Shimadzu SPD-20A Prominence UV-Visible detector. Correlation coefficient values are 0.9998 and 0.9996, respectively. The specificity, linearity, accuracy (established by % recovery), precision (repeatability and intermediate precision), the sensitivity (limit of detection and limit of quantitation), and robustness were validated for methylparaben and butylparaben in skin ointment product. The validation results fulfilled the acceptance criteria of validation method based on ICH Guideline.


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JOURNAL OF BIOCHEMICAL TECHNOLOGY
JOURNAL OF BIOCHEMICAL TECHNOLOGY
Journal of Biochemical Technology is a peer reviewed International Journal published by the Sevas Publishing on behalf of the Biochemical Technology Society, a Registered Charity Organization from India

AREA OF INTEREST
AREA OF INTEREST
Areas of high interest, cover new advances in enzymatic and protein mechanims; applied molecular genetics and biotechnology; genomics and proteomics; metabolic; medical, environmental, food and agro biotechnology.

FOCUS AND SCOPE
FOCUS AND SCOPE
Journal Of Biochemical Technology” Provides A Medium For The Rapid Publication Of Full-Length Articles, Mini-Reviews Of New And Emerging Products And Short Communications On All Aspects Of ...

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This journal provides immediate open access to its content on the principle that making research freely available to the public supports a greater global exchange of knowledge. Keywords include, Biochemical Research: Endo/exocytosis, Trafficking, Membrane Biology, Cell Migration, Cell-Matrix Organelle Biogenesis, Cytoskeleton Proteolysis, Cell Death, Cell Cycle, Cancer, Cell Growth/Death, Differentiation, Drug Targets, Gene Therapy, Models of Disease, Proteomics, Stem Cells, Bioenergetics, Mitochondria, Free Radicals, Redox Signaling, Ion Transport/Channels, Oxidative